Sample Size and Power

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Vocabulary • Arm = <strong>Sample</strong> = Group • Demonstrate superiority – Detect difference between treatments • Demonstrate equally effective – Equivalence trial or a 'negative' trial – <strong>Sample</strong> size required to demonstrate equivalence larger than required to demonstrate stateada difference ee • Demonstrate non-inferiority – Lots of issues
Superiority vs. Equivalence Superiority Superiority
Page 1 and 2: Sample Size and Power Laura Lee Joh
Page 3 and 4: Misconceptions • A small p-value
Page 5: Take Away Message • Get some inpu
Page 9 and 10: Vocabulary (2) • Follow-up period
Page 11 and 12: Power Depends on Sample Size • Po
Page 13 and 14: Power Changes • 2n = 32, 2 sample
Page 15 and 16: Power should be….? • Phase III:
Page 17 and 18: Outline Power ‣Basic Sample Size
Page 19 and 20: Basic Sample Size Information • W
Page 21 and 22: Take Away • Study’s primary out
Page 23 and 24: Sample Size Formula Information •
Page 25 and 26: Sample Size & Study Design • Rand
Page 27 and 28: Phase I: Dose Escalation • Dose l
Page 29 and 30: Phase I (cont.) • Maximum Tolerat
Page 31 and 32: Phase I Enroll 3 people 0/3 DLT 1/3
Page 37 and 38: Number of pts with DLT Decision 0/3
Page 39 and 40: Phase I • MANY new methods • Se
Page 41 and 42: Phase II Design Problems • Might
Page 43 and 44: Phase II Example: Two-Stage Optimal
Page 45 and 46: Table from Simon (1989)
Page 47 and 48: Phase II Example • Initially enro
Page 49 and 50: Sample Size Differences • If the
Page 51 and 52: Phase II: Historical Controls • W
Page 53 and 54: Study Design Phase II Summary Advan
Page 55: Number of Patients to Enroll? • 1
Page 58:
Phase III Survival • Look at nomo
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1-Sample N Example • Study effect
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Short Helpful Hints • In humans n
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Sample Size: Iteration and the Use
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Sample Size: Change Standard d Devi
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Sleep Aid Example: 2 Arms Investiga
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Sample Size: Change Effect or Diffe
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Sample Size: Change Standard d Devi
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Live Statistical Consult! • Sampl
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Sample Size Rulers
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Put in 1-Sample Example #s • 1 ar
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Put in 2-Sample Example #s • 2 ar
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Other Designs?
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Examples in the Text • Several wi
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Take Home: What you need for N •
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Outline Power Basic sample size inf
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K:1 Sample Size Shortcut • Use eq
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How many controls? k = 2n n 0 − n
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Formulas and Example Risk of event
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Balanced Designs: Easier to Find Po
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Multiple Comparisons • If you hav
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Outline Power Basic Sample Size Inf
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No Prior Information • "Sample si
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Number of Available Patients • "T
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Conclusions: What Impacts Sample Si
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Top 10 Statistics Questions 10.Exac
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Top 10 Statistics Questions 4. Inte
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Analysis Follows Design Questions
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Resources: General/Text Books • A
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Resources: Articles • Simon R. Op
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Resources: FDA Guidance • http://
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Questions?
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